Chimerix, a US-based company which discovers, develops and commercializes oral antiviral therapeutics, has won the US Food and Drug Administration (FDA) fast track designation for CMX001 for the prevention of cytomegalovirus (CMV) infection.
The broad spectrum, oral nucleotide analog lipid-conjugate, CMX001, works by blocking the replication of double-stranded DNA (dsDNA) viruses.
The company previously completed Phase II clinical development of CMX001 targeting the prevention of CMV infection in adult hematopoietic stem cell transplant (HSCT) recipients and is expecting to commence SUPPRESS study in 2013.
SUPPRESS is a Phase III study of CMX001 for the prevention of CMV infection in adult HSCT recipients.
CMX001 has earlier obtained FDA fast track designation for pre-emptive treatment of adenoviral disease in post HSCT patients and for the treatment of smallpox.
